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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

The FDA Law Blog

OGDP is one of several offices in OGD, and it was composed of three divisions: the Division of Legal and Regulatory Support, the Division of Orange Book Publication and Regulatory Assessment, and the Division of Policy Development (DPD). Providing significant policy support to the annual update of the Orange Book Preface.

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Prosecutors: Convicted CEO Elizabeth Holmes is a flight risk

STAT

(AP) — Elizabeth Holmes is a flight risk and shouldn’t be allowed to stay out of prison while she appeals her 11-year prison sentence for defrauding investors, federal prosecutors said in court documents. Holmes had a one-way plane ticket to Mexico booked for Jan.

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White paper reveals pathway for digital therapeutics use in Italy

pharmaphorum

The book features insights and recommendations from 40 leading experts in the field, who hope that Italy will begin to follow in the footsteps of early adopters of digital therapeutics such as Germany, France and the US. “At The post White paper reveals pathway for digital therapeutics use in Italy appeared first on.

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Top 5 takeaways from international hybrid and virtual meeting guidance for pharma

pharmaphorum

Since COVID-19 reared its head more than two years ago, the traditional hustle and bustle of in-person annual congresses have largely been consigned to the history books. Here, we take a look at the top five takeaways from the document: 1. The codes still apply. End of the host country. Follow the path of most resistance.

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The Re-Invention of CSV Templates and Pros & Cons

ISPE

It often took me multiple weeks of Computer Based Training (CBT) and reading documents. I created the templates in my own time and first only used them for my own information, as a reference book, instead of using the regulations to review compliance of CSV documents and controls. Several times I even didn’t pass the exams.

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AXA partners Microsoft on ‘all-in-one’ digital health platform

pharmaphorum

The aim is to develop an “all-in-one” digital platform featuring a self-assessment tool, a personalised medical concierge service for appointment booking, and teleconsultations, along with home care service like medicine delivery.

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Maximizing the MTPC Framework for Current and Future Pharmacists

PQA

In documentation of the care provided, the MTP Categories Framework promotes consistent identification of MTPs found and the interventions taken to resolve MTPs within MTM services. It is clear to me that this rational approach is vital for practice standardization and documentation.